21 CFR 606 - Blood Industry

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US FDA Title 21 CFR Parts

Part 606 - Current Good Manufacturing Practice for Blood and Blood Components

21 CFR Part 606 outlines the Current Good Manufacturing Practice requirements for blood establishments. 21 CFR Part 606 was designed and is used to ensure that blood and blood components for human use are safe, pure, and effective. The Center for Biologics Evaluation and Research (CBER) also specifies in its Compliance Program that inspections are conducted to make sure that blood establishments meet process and production controls, equipment regulations, and quality assurance requirements found in 21 CFR Part 211.